# K140094: Springtms Total Migraine System

- Pathway: 510(k) (Traditional)
- Applicant: Eneura Therapeutics, LLC
- Decided: May 21, 2014 after 127 days
- Product code: OKP (Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache)
- Device class: 2
- Regulation: 21 CFR 882.5808
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN130022 (2013). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130022: Neuralieve Cerena Transcranial Magnetic Stimulator, Eneura Therapeutics (2013). Our reading of the summary gave K130556, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130022, Neuralieve Cerena Transcranial Magnetic Stimulator (Eneura Therapeutics), granted Dec 13, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K162797: SpringTMS (2017), 2 descendants of its own
- K182976: SpringTMS (2019), 1 descendant of its own
- K230358: SAVI Dual (TM) Migraine Therapy (2023), 0 descendants of its own
- K161663: sTMS mini (2016), 0 descendants of its own

## Indications for use
The eNeura Therapeutics® Spring TMS® is indicated for the acute treatment of pain associated with migraine headache with aura.

Source page: https://510kreport.com/device/K140094
Methodology: https://510kreport.com/methodology